Kornimate/medical-research-clean huggingface dataset:
preventing and arresting dental root surface caries in community-dwelling older adults

Conditions: Dental Caries

Summary: this study is a randomized clinical trial lasting for 30 months. a total of 300 subjects will be recruited from social centres for elders located in different districts in hong kong. baseline clinical examination will be conducted by a single calibrated examiner in the social centres using an intra-oral led light, mouth mirrors and probes. subjects will be randomly allocated into the three study groups and receive interventions accordingly. follow-up examinations at 6-month intervals will be carried out to assess the clinical outcomes, i.e. whether new root caries has developed and whether the active root caries found at baseline have become arrested (remineralized and hardened) or not. photographs of the arrested lesions will be taken to assess their colour. results of this study will provide the much needed evidence to guide the dental professionals in hong kong and worldwide in deciding on the most appropriate intervention for the prevention and treatment of this common dental disease of the older adults.

the primary and secondary outcome of this study was new root caries and arrested root caries. a root surface with new caries experience was recorded when a root surface which was sound at baseline was found to have a carious lesion or a filling at a follow-up examination. arrested root caries was recorded when the active root caries found at baseline changed into inactive root caries at follow-up. the status of each root surface was recorded using the codes recommended by the international caries detection and assessment system (icdas ⅱ) coordinating committee in 2009. color of the arrested root caries lesion was classified into one of four types according to pantone® color plates placed next to the lesion (fig 1), namely yellow (7401u), light brown (1245u), dark brown (4635u), and black (black u). a mean root caries increment of around 0.8 root surface per year of control group was reported in a previous clinical trial conducted in hong kong. thus, in this study, a 30-month increment of 2 new decayed root surfaces was anticipated. the ratio of the mean to the standard deviation of the root caries increment was expected to be around 1:1.5. in order to show that a 50% difference in mean caries increment between the highest and the lowest values in the three groups was statistically significant at a 5% significance level and at an 80% power, 80 subjects in each group was required. allowing for a drop-out rate of 25% over 30 months, a total of 300 subjects (100 in each group) were needed.

Eligibility criteria:
inclusion criteria: * have at least 5 teeth with exposed root surfaces and not indicated for extraction, and * living in the community and have self-care ability for normal daily activities. exclusion criteria: * have life-threatening or serious health problems, * have cognitive problems in communication or in receiving oral hygiene instructions * have salivary gland diseases or received radiotherapy in the head and neck region.
compressive cryotherapy versus conventional cryotherapy after total knee arthroplasty

Conditions: Knee Arthropathy; Cryotherapy Effect

Summary: in the postoperative period of a total knee arthroplasty, subjects present limitations of articular amplitudes, swelling, pain and functional limitations. functional rehabilitation is unanimously recommended, including the use of cryotherapy. however, there is no consensus regarding the methods of application of cryotherapy. thus the objective of the study is to compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement of mobility, swelling, pain and functional parameters. the 2 cryotherapies were a compressive cryotherapy and a so-called classic cryotherapy by cold pack.


Eligibility criteria:
inclusion criteria: * volunteers * first-line total knee arthroplasty on an indication of knee osteoarthritis diagnosed by radio-clinical examination * between d3 and d10 postoperatively * age \< 90 years. exclusion criteria: * intolerance to cryotherapy or compression, * occurrence of complications secondary to surgery, * withdrawal of consent, * non-compliance with the rehabilitation protocol (content and dosage of sessions).
cardiovascular lifestyle study: effects and expense of a cardiovascular risk reduction clinic in primary care

Conditions: Hypertension; Hyperlipidemia; Hyperglycemia; Cardiovascular Disease; Smoking

Summary: the purpose of this trial is to study the effects on risk reduction and expense of 3 approaches to the care of people with cardiovascular risk factors in a naturalistic primary care environment.

background: uncontrolled hypertension, hyperlipidemia, hyperglycemia, smoking and other cardiovascular risks remain at epidemic proportions despite known efficacious treatments. issues of both provider and patient behavioral non-adherence to guidelines and therapeutic regimes, respectively, are key factors in non-control. few interventions aimed at reducing cardiovascular risk factors are based on sound theories of behavior change. objective: to assess the effectiveness and expense of three approaches to the care of persons with known risks for cardiovascular disease. the three treatment approaches are usual care, usual care plus nurse telephone calls, and usual care plus clinic visits to a nurse and/or physician. design: patients will be randomized to a 1) specialized proactive, and holistic cardiovascular risk management clinic using principles of behavior change; 2) nurse telephone calls as an attention placebo, yet a low dose, health promotion intervention; and 3) usual primary care. a random sample of 670 patients with cardiovascular risks identified in the past five years will be selected. patients will be excluded if they do not speak english, are cognitively impaired or live in a nursing home. interview questionnaires will measure cardiovascular risk, intention to change, social support, depression, coping and health services use. in addition, patients will be required to give a blood sample to measure cholesterol and glucose levels. patients will then be randomized to one of three treatment groups. significance: the expected findings of this study is that the cardiovascular clinic, with nurse and physician, will be most effective at reducing cardiovascular risk and will pay for itself by averting hospital and emergency use for cardiovascular events.

Eligibility criteria:
inclusion criteria: * a random sample of all persons with visits to their primary care physician for cardiovascular risks in past year. cognitively intact (mini-mental state) or living with a carer who is cognitively intact. all other co-morbidities exclusion criteria: * presently in a nursing home or in-patient long-term care facility (already receiving medications and diets as prescribed). no available family/friend interpreter if non-english speaking.

Keywords: cardiovascular risks motivational interviewing behavior change primary care setting
a study of the absorption, metabolism, and excretion of gbt440 in healthy male subjects

Conditions: Anemia, Sickle Cell

Summary: this study will provide information regarding the metabolic pathway of gbt440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. the administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of gbt440, providing further quantitative information on the disposition of gbt440. the results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of gbt440.


Eligibility criteria:
inclusion criteria: 1. healthy; non-smoking male; 18 to 55 years old, inclusive 2. weighs at least 50 kg and not more than 110 kg 3. agrees to use contraception 4. willing and able to give written informed consent exclusion criteria: 1. evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder 2. history of stomach or intestinal surgery that would potentially alter drug absorption 3. history of hypersensitivity or allergy to drugs, foods, or other substances 4. history or presence of abnormal electrocardiogram 5. exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months of screening 6. participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening
a trial comparing lantus algorithms to achieve normal blood glucose targets in subjects with uncontrolled blood sugar with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: * to determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia. secondary objectives: * to determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia. * to determine the difference in glycaemic control as measured by hba1c and fasting blood glucose between the treatment algorithms. * to determine the difference in glycaemic control as measured by hba1c and fasting blood glucose between baseline and end of treatment. * to obtain safety data on the use of insulin glargine in each treatment algorithm. * to measure change in subject weight and insulin dose between baseline and end of treatment. * to determine subject quality of life and treatment satisfaction (sub-study)


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus, * subjects on antidiabetic treatment (oral and/or insulin therapy) for \> 6 months, * subjects who require a basal long-acting insulin for the control of hyperglycaemia, * hba1c values \> 7.0% and \< 12 %, * bmi \< 40 kg/m². the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
anrs hc20 effectiveness of an optimized anti hcv pegifn-alpha2a + ribavirin on sustained virological response in patients with hcv genotype 1 and 4 non responders and co-infected with hiv

Conditions: Hepatitis

Summary: the purpose of this study is to assess the effectiveness of an optimized anti hcv treatment (360μg per week of pegifn-alpha2a + 18mg/kg/j of ribavirin for 6 months.

in patients hiv infected, the success rate do not exceed 20% in genotype 1 or 4 patients. in case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. the new molecules are not yet available for patients co-infected with hiv, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments. however, recent studies show that it is possible to propose a new treatment "optimized" to these patients in the hope to obtain better success rate. provide antiretroviral treatment, use of high doses of peg-interferon and ribavrine, and supporting patients.

Eligibility criteria:
inclusion criteria: * age over 18 years * weight 85 kg below the pre-inclusion visit. * documented hiv infection (hiv positive) * hcv infection documented by a positive pcr * hcv genotype 1 or 4 * compensated liver disease (child-pugh below/equal to 6) * lymphocytes cd4 above 200/mm3 * patient not answering a treatment for hepatitis c. * patient not covered by dual by peg-ifn + riba for at least three months (wash out) exclusion criteria: * co-infection with hbv (hbsag positive) * neutropenia below 1000/mm3 * thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3. * hemoglobin below 11 g / dl (men and women) * arguments radiological (ultrasound, ct or mri) of hepatocellular carcinoma cell * antiretroviral containing didanosine (ddi) and stavudine (d4t) and zidovudine (azt) and abacavir (abc).

Keywords: hcv genotype 1, 4 virological response ribavirin pegpegifn- alpha 2a viral hepatitis (hcv)
inhibition of aldosterone in patients with chronic renal disease

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. the hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.

patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. it is accepted that proteinuria is a surrogate measurement for progression. if proteinuria can be lowered we hope to prolong patients pre-dialysis phase. our theory is that aldosterone inhibition will lead to this. for a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. blood pressures will be kept at the same level using other drugs.

Eligibility criteria:
inclusion criteria: * proteinuria \> 500 mg/24 hours * hypertension or anti-hypertensive treatment exclusion criteria: * diabetic nephropathy * gfr\< 20 ml/min * p-potassium between 3,5 mmol/l and 5,0 mmol/l

Keywords: kidney failure, chronic proteinuria aldosterone renin-angiotensin system
cancer prevention & online technologies

Conditions: Skin Cancer

Summary: the overall goal of this research is to develop interventions that leverage online technology (e.g. ads, social media) to reduce individuals' skin-cancer-related risk behaviors and ultimately to reduce skin cancer incidence.

this research includes three phases: 1. to better understand the motivators and inhibitors of skin cancer risk behaviors in various populations including use of indoor tanning and outdoor sun exposure; 2. to develop content messages and images related to skin cancer risk that are resonant with various populations; 3. to test the relative effectiveness of these messages in reducing likelihood of or actual skin cancer risk behaviors in various populations.

Eligibility criteria:
inclusion criteria: * facebook user between the age of 18 and 65 * self-identifies as male * profile indicates interest in at least one of the following: lgbt community, lgbt culture, lgbt social movements, rainbow flag, gay pride, gay-friendly, homosexuality exclusion criteria: * failure to meet inclusion criteria
the impact of bariatric surgery on adipocyte metabolism

Conditions: Metabolic Syndrome; Obesity

Summary: the purpose of this study is to understand how daily rhythms of behavior affect the expression of genes in fat cells, and how these daily cycles affect the way fat cells respond to insulin (a hormone that controls blood sugar levels) before and after bariatric surgery.

bariatric surgery as a means of weight loss has become increasingly popular over the last 10-15 years. in addition to promoting weight loss, bariatric surgery has become increasingly recognized for use in the management of diabetes. recent studies have indicated that bariatric surgery can result in a marked improvement in insulin sensitivity before long term weight loss is attained. the goal of this project is to delineate the changes in the insulin responsiveness of subcutaneous adipocytes obtained by needle biopsy 2 weeks prior to surgery vs. 12 weeks after bariatric surgery, which could account for improvements in overall insulin sensitivity seen before any long-term sustained weight loss has occurred. the investigators will also examine gene expression in adipocytes (fat cells).

Eligibility criteria:
obese subjects inclusion criteria: * 18-55 years old * female * bmi greater than 40 kg/m2 * scheduled for bariatric surgery at the center for the surgical treatment of obesity at the university of chicago * signed informed consent exclusion criteria: * male * diagnosed with a systemic illnesses, including heart, renal, liver, or malignant disease * uncontrolled hypertension (blood pressure greater than 140 mmhg systolic and 90 mmhg diastolic without medication) * use of beta blockers * hemoglobin less than 11.5g/dl * known allergy to lidocaine * pregnancy * lactation * subjects will not have undergone surgery, donated a unit of blood, or participated in another clinical study within the last 4 weeks prior to consent. * post-menopausal non-obese subjects inclusion criteria: * 18-55 years old * female * bmi less than 30 kg/m2 * signed informed consent exclusion criteria: * male * diagnosed with a systemic illnesses, including heart, renal, liver, or malignant disease * uncontrolled hypertension (blood pressure greater than 140 mmhg systolic and 90 mmhg diastolic without medication) * use of beta blockers * hemoglobin less than 11.5g/dl * known allergy to lidocaine * pregnancy * lactation * subjects will not have undergone surgery, donated a unit of blood, or participated in another clinical study within the last 4 weeks prior to consent. * post-menopausal

Keywords: insulin adipocyte gene expression
influence of tumor associated immunity on the number of lymph node retrieved after colorectal cancer surgery (preliminary study)

Conditions: Colorectal Cancer

Summary: hypothesis of this study is that increased immunity of primary tumor affects the increased number of lymph node retrieved. this study investigates whether immunity-related cytokine expression on primary tumor, colonic mucosa, and serum is associated with the number of lymph node retrieved in colorectal cancer patients.


Eligibility criteria:
inclusion criteria: * 1. histologically confirmed colorectal cancer 2. non-metastatic cancer (ctnm i, ii, or iii) 3. over 20 years of age 4. curative resection (r0) exclusion criteria: * 1. patient with distant metastasis 2. history of chemotherapy or radiation therapy for malignancy 3. patient receiving immunosuppressive or anti-inflammatory treatment 4. hereditory colorectal cancer 5. preoperative chemoradiation therapy for colorectal cancer 6. pregnancy 7. emergency
outcome of different pathogenic mutations in hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: this is a prospective, single-center study to assess clinical phenotype and prognosis of different pathogenic mutations in chinese patients with hypertrophic cardiomyopathy. patients with hypertrophic cardiomyopathy were consecutively recruited, and then dna samples were extracted from peripheral blood. targeted sequencing of 142 genes was performed to obtain variants associated with hypertrophic cardiomyopathy. patients will undergo face-to-face interviews, phone calls, or/and chart reviews at 6 months, 12 months, 24 months, 36 months, 48 months and 60 months for data collection of clinical outcomes.


Eligibility criteria:
inclusion criteria: * 1. adults: a wall thickness ≥15 mm in one or more lv myocardial segments-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging (cmr) or computed tomography (ct))-that is not explained solely by loading conditions; * 2. children: an lv wall thickness more than two standard deviations greater than the predicted mean (z-scored\>2, where a z-score is defined as the number of standard deviations from the population mean); * 3. relatives: the first-degree relatives of patients with unequivocal disease (lvh ≥15 mm) is based on the presence of otherwise unexplained increased lv wall thickness ≥13 mm in one or more lv myocardial segments, as measured using any cardiac imaging technique \[echocardiography, cardiac magnetic resonance (cmr) or ct\]. exclusion criteria: * 1. patients with severe valvular disease, aortic stenosis, congenital heart disease, hypertensive heart disease, diabetic cardiomyopathy, or other cardiovascular or systemic diseases that may cause ventricular hypertrophy; * 2. patients who had participated in any clinical trial during the first 3 months; * 3. previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix); * 4. patients refused to comply with the requirements of this study to complete the research work.

Keywords: pathogenic mutations clinical phenotype prognosis
patients with alzheimer's disease or related youth disease

Conditions: Alzheimer Disease, Early Onset; Lewy Body Disease; Frontotemporal Lobar Degeneration

Summary: this study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in north of france.


Eligibility criteria:
inclusion criteria: as part of this study, patients will be considered: * residing in the departments of nord (59) and pas-de-calais (62), * whose diagnosis of alzheimer's disease or related illness (dlft, dcl) was made and announced, * whose diagnosis of illness was made after 2007 * whose first symptoms appeared before the age of 60 patients included in the comaj cohort and those who completed the pathways medical and social booklet will have to meet these criteria to be selected for this study. as part of the survey, caregivers of patients meeting the above criteria and the following two will be recruited: * having consulted or being followed by liberal neurologists or in hospital memory consultations (excluding cmrr-cnr-maj lille) of the departments of nord and pas-de-calais, * not monitored at the cmrr-cnr-maj lille (ad hoc notice possible). the caregiver is defined as a family member or friend who helps regularly by doing the necessary tasks so that the sick person can keep as much autonomy as possible. exclusion criteria: * aged under 18 * no social coverage * refusal to sign informed consent form